A randomized, therapy controlled, double blind, single center cross-over pilot study to evaluate the antihypertensive and pleiotropic effects of telmisartan in comparison to amlodipin on myocardial diastolic function , vascular function and carbohydrate metabolism in 30 patients with metabolic syndrome, mild to moderate hypertension and without overt coronary artery disease - telmipleio
- Conditions
- patients with metabolic syndrome, mild to moderate hypertension and without overt coronary artery disease
- Registration Number
- EUCTR2005-005206-23-DE
- Lead Sponsor
- 3.Med. Department, Academic Hospital Bogenhausen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
patients with metabolic syndrome,
•both sexes,
•age 30 – 80 years,
•mild to moderate hypertension potentially on treatment,
•normo- or hyperlipidemia potentially on statin therapy,
• normal systolic LV function,
•in sinusrhythm,
•patient agreement signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•contraindications for either telmisartan or amlodipin
•malignant hypertension
•major complications of macrovascular disesase,
•overt coronary artery disease,
•patients, who lack inclusion criteria
•manifest drug or alcohol abuse or psychiatric disease (such as depression, schizophrenia, anorexia nervosa)
•malignat disease and other severe disease (such as liver cirrhosis, chronic infectious disease) which could interfere with interpretation of blood chemistry data or ultrasound data
•participation in another study simultaneously
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method